Alethia™ Mycoplasma Direct

FDA UDI

Class II (US FDA UDI)

by Meridian Bioscience, Inc.

Identity

Trade Name: Alethia™ Mycoplasma Direct FDA UDI
Generic Name: Mycoplasma pneumoniae nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
Device Name: The Alethia Mycoplasma Direct DNA amplification assay, performed on the Alethia Reader, is a qualitative in vitro diagnostic test for the direct detection of DNA from Mycoplasma pneumoniae in human throat swabs obtained from patients suspected of having Mycoplasma pneumoniae infection. The Alethia Mycoplasma Direct assay utilizes loop-mediated isothermal DNA amplification (LAMP) technology to detect Mycoplasma pneumoniae by targeting a segment of the Mycoplasma pneumoniae genome. Results from the Alethia Mycoplasma Direct DNA amplification assay should be used in conjunction with clinical presentation, other laboratory findings, and epidemiological risk factors as an aid in the diagnosis of Mycoplasma infection and should not be used as the sole basis for treatment or other patient management. Positive results do not rule out co-infection with other organisms and negative results in persons with respiratory tract infections may be due to pathogens not detected by this assay. Lower respiratory tract infections due to M. pneumoniae may not be detected by this assay. If lower respiratory tract infection due to M. pneumoniae is suspected, additional laboratory testing using methods other than the Alethia Mycoplasma Direct DNA Amplification Assay may be necessary. FDA UDI
Model / Reference: 480250 FDA UDI
Description: The Alethia Mycoplasma Direct DNA amplification assay, performed on the Alethia Reader, is a qualitative in vitro diagnostic test for the direct detection of DNA from Mycoplasma pneumoniae in human throat swabs obtained from patients suspected of having Mycoplasma pneumoniae infection. The Alethia Mycoplasma Direct assay utilizes loop-mediated isothermal DNA amplification (LAMP) technology to detect Mycoplasma pneumoniae by targeting a segment of the Mycoplasma pneumoniae genome. Results from the Alethia Mycoplasma Direct DNA amplification assay should be used in conjunction with clinical presentation, other laboratory findings, and epidemiological risk factors as an aid in the diagnosis of Mycoplasma infection and should not be used as the sole basis for treatment or other patient management. Positive results do not rule out co-infection with other organisms and negative results in persons with respiratory tract infections may be due to pathogens not detected by this assay. Lower respiratory tract infections due to M. pneumoniae may not be detected by this assay. If lower respiratory tract infection due to M. pneumoniae is suspected, additional laboratory testing using methods other than the Alethia Mycoplasma Direct DNA Amplification Assay may be necessary. FDA UDI

Identifiers

Catalog Number: 480250 FDA UDI
Primary DI / UDI-DI: 00840733102189 FDA UDI
510(k) Number: K160829 FDA UDI
FDA Product Code: OOI FDA UDI
OZX FDA UDI
GMDN Term: Mycoplasma pneumoniae nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 862.2570 FDA UDI
866.3980 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Mycoplasma pneumoniae nucleic acid IVD, kit, nucleic acid technique (NAT)

Alethia™ Mycoplasma Direct by Meridian Bioscience, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K160829 also covers:

Alethia™ Mycoplasma Direct External Control Kit — MERIDIAN BIOSCIENCE, INC.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Meridian Bioscience, Inc.

Sources (1)

FDA UDI 20099556-e714-4378-a540-5c98587474db 37 fields · synced May 30, 2026